Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Subjects were screened and enrolled at 10 sites in the US and 5 sites in Thailand.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

AmphoB Standard

Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.

AmphoB+Fluc400

Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.

AmphoB + Fluc800

Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

AmphoB Standard

Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.

AmphoB+Fluc400

Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.

AmphoB + Fluc800

Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.

Reporting Groups

Description

AmphoB Standard

Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.

AmphoB+Fluc400

Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.

AmphoB + Fluc800

Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.

Measured Values

AmphoB Standard

AmphoB+Fluc400

AmphoB + Fluc800

Number of Participants Analyzed
[units: participants]

45

47

49

Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug
[units: Events]

Hypomagnesaemia

2

1

0

Hypokalaemia

0

0

1

Anaemia

1

1

0

Drug intolerance

1

0

0

Creatinine renal clearance increased

0

0

1

Psychotic disorder

0

0

1

No statistical analysis provided for Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug

2. Primary:

Number of Dose-limiting Toxicities Attributed to Treatment Regimens [ Time Frame: Day 100 ]